SECQURE Ultimate

GUDID 00863634000484

Suction / Irrigation Set with Dual Spike

SECQURE SURGICAL, CORP.

Surgical irrigation/aspiration tubing set
Primary Device ID00863634000484
NIH Device Record Key6a76e71c-d79c-43bf-ad6c-8c0e15f16699
Commercial Distribution StatusIn Commercial Distribution
Brand NameSECQURE Ultimate
Version Model NumberCQ3850ULT
Company DUNS079554198
Company NameSECQURE SURGICAL, CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100863634000484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HETLaparoscope, Gynecologic (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2017-09-19

On-Brand Devices [SECQURE Ultimate]

00863634000491Suction / Irrigation Set with Single Spike
00863634000484Suction / Irrigation Set with Dual Spike
00863634000477EndoRetrieval Pouch with 10mm Introducer & 130mm x 180mm Pouch
00863634000460EndoRetrieval Pouch with 10mm Introducer & 90mm x 145mm Pouch
00863634000453Autoshield Trocar, Threaded Cannula, 5mm x 70mm, with Additional Cannula
00863634000446Dilating Tip Trocar, Threaded Cannula, 12mm x 100mm
00863634000439Dilating Tip Trocar, Threaded Cannula, 10mm x 100mm
00863634000422Dilating Tip Trocar, Threaded Cannula, 5mm x 100mm
00863634000415Autoshield Trocar, Threaded Cannula, 12mm x 100mm
00863634000408Autoshield Trocar, Threaded Cannula, 10mm x 100mm

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